UPDATE: Kezar Life Sciences Terminates Phase 2b Study of Zetomipzomib for Lupus Nephritis Treatment
Kezar Life Sciences announced the termination of Phase 2b PALIZADE clinical trial of zetomipzomib, an investigational therapy for lupus nephritis (LN). This follows the clinical trial hold placed by the U.S. Food and Drug Administration (FDA), which came after Kezar Life Sciences reported they had voluntarily ended enrollment and dosage of PALIZADE at the recommendation of the trial’s Independent Data Monitoring Committee (IDMC).
The PALIZADE study was a global, randomized, double-blind Phase 2b clinical trial that evaluated the efficacy and safety of two dose levels (30 mg and 60 mg) of zetomipzomib compared to the placebo and standard therapy in patients with active LN. There were 84 people participating in the study. The IDMC recommended trial suspension and halting dosage of zetomipzomib after they reviewed emerging safety data which revealed the death of four study participants in the Philippines and Argentina.
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